BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.7MM CABLE WITH CRIMP 750MM-STERILE

    MDR report key: 6122847 · Received November 22, 2016

    Report

    Report Number
    1719045-2016-10846
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    December 30, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDQ
    PMA / PMN Number
    K992616
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT CODE (B)(4) REFERS TO REVISION SUGERY FROM (B)(6) 2013 WHERE PATIENT HAD HIS LEFT HIP EXPLANTED, PLACEMENT OF A TEMPORARY ANTIBIOTIC CEMENT SPACER AND OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMUR. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THERE IS NO ALLEGATION OF A COMPLAINT AGAINST THIS DEVICE, THERE IS NO REPORTED MALFUNCTION. THIS DEVICE WAS REMOVED AS PART OF A PLANNED REVISION SURGERY AND THERE WAS NO ALLEGATION OF MALFUNCTION REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS DETERMINATION WILL BE RE-REVIEWED BY A CLINICIAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PATIENT HEIGHT REPORTED AS 5 FEET 11 INCHES. ADDITIONAL EVENTS WERE CAPTURED BY DEPUY JOINT RECONSTRUCTION. (B)(4). DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE HISTORY RECORD REVIEW CONCLUDED THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION FOR PART #298.801.01S, SYNTHES LOT #P149378, LOT #P149378, RELEASE TO WAREHOUSE DATE:16-MAY-2013, EXPIRATION DATE: 31-MAR-2018 AND SUPPLIER: (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ADVANCED OSTEOARTHRITIS AND AVASCULAR NECROSIS IN THE LEFT HIP RELATED TO AN WORK INJURY. HE HAD A LEFT TOTAL HIP ARTHROPLASTY (B)(6) 2009. THE PATIENT DEVELOPED PAIN IN THE LEFT HIP AND WAS DIAGNOSED WITH CHRONIC INFECTION IN THE LEFT HIP ARTHROPLASTY. ON (B)(6) 2013, THE PATIENT HAD HIS LEFT HIP EXPLANTED, PLACEMENT OF A TEMPORARY ANTIBIOTIC CEMENT SPACER AND OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMUR. EIGHT SYNTHES CERCLAGE WIRES WERE USED TO REAPPROPRIATE THE BONE ONTO THE PROSTALAC, RE-ESTABLISHING THE FEMORAL TUBE. ON (B)(6) 2013, THE PATIENT HAD ANOTHER LEFT HIP REVISION, REMOVAL OF TEMPORARY ANTIBIOTIC CEMENT SPACER, SCAR REVISION, PREVIOUS CERCLAGE WIRES WERE REMOVED AND AN (ORIF) GREATER TROCHANTER. THE PATIENT WAS DOING WELL, BUT REMOVED THE HIP ABDUCTION BRACE AND SUSTAINED A GREATER TROCHANTERIC FRACTURE DUE TO WEAKENED BONE FROM THE SURGERY. ON (B)(6) 2014, THE PATIENT UNDERWENT A LEFT HIP (ORIF), FEMORAL STRUT GRAFT PLACING AND SCAR REVISION. THE PATIENT CONTINUED TO DRAIN POST-OPERATIVELY BUT HAD PURULENT DRAINAGE, WOUND DEHISCENCE WITH A FOUL ODOR. ON (B)(6) 2014, THE PATIENT HAD LEFT HIP IRRIGATION, DEBRIDEMENT AND PLACEMENT OF RE-ABSORBABLE ANTIBIOTIC CEMENT PELLETS. FINAL PATIENT OUTCOME UNKNOWN. THIS IS REPORT NUMBER 6 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774042 1.7MM CABLE WITH CRIMP 750MM-STERILE CERCLAGE FIXATION JDQ SYNTHES MONUMENT P149378

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention